PMA P080011S190

Device: Biofinity XR Toric (comfilcon A)
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S190
Product code: LPM
Decision date: 2025-07-14
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: implementation of a new manufacturing line and sterilization cycle at the Cooper Vision, Inc. facility located in Scottsville, NY, and the transfer of minifiles from the Hamble, UK facility to the Juana Diaz, PR facility

Current openFDA PMA Record#

Device: Biofinity XR Toric (comfilcon A)
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S190
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-07-14
Decision code: OK30
Date received: 2025-06-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of a new manufacturing line and sterilization cycle at the Cooper Vision, Inc. facility located in Scottsville, NY, and the transfer of minifiles from the Hamble, UK facility to the Juana Diaz, PR facility